l. Field of the Invention
This invention pertains generally to the field of medical and surgical devices, and more particularly to the field of devices for holding or supporting endotracheal tubes during medical treatment or surgery.
2. Description of the Prior Art
During medical treatment or surgery it is often necessary to provide an unobstructed passage or airway to the patient's lungs to administer oxygen or to facilitate breathing. This problem arises especially during acute situations involving blockage of the mouth, throat or tracheal passage by blood, mucus, or other foreign material. The problem is solved by insertion of an endotracheal tube through the patient's mouth and into the trachea to provide a free flow of air or oxygen. This tube must be maintained in its proper position for extended periods of time. It is desirable to provide means other than manual for holding this tube in place so that the surgeon's or technician's hands are free for other activities during treatment.
A common and typical method for maintaining the position of the endotracheal tube is by means of adhesive tape placed over the patient's mouth and wrapped around the tube. This traditional method is inconvenient and time consuming, and suffers from several drawbacks. Generally a considerable amount of tape is required, and in medical emergency situations valuable time must be spent taping the tube in place. Once the tube has been secured by this method it will remain in place only temporarily, because sweat, saliva, blood, or other secretions are absorbed by the adhesive tape, causing it to loosen and allowing the tube to become displaced. Therefore the tape must be removed periodically and fresh tape must be applied. Even when fresh adhesive tape is used, considerable skill is required to wrap the tape in such a manner as to hold the tube immobile because of the inherent flexibility of the tape. Further, the adhesive tape obstructs the patient's mouth so that blood or other foreign fluids cannot be removed by a suction tube while the endotracheal tube is in place, unless the suction tube is also rendered immobile by the tape and both tubes are installed simultaneously. Finally, this use of adhesive tape causes considerable discomfort to the patient.
Several devices have been developed in the past to attempt to overcome some of these and other drawbacks of the adhesive tape method for supporting endotracheal tubes. One typical device is disclosed in U.S. Pat. No. 3,774,616 (White, et al.) which teaches an endotracheal tube holder fastened to a face plate, bite block and airway fitting into and over the patient's mouth. The entire configuration is held in place by an adjustable strap passing around the patient's upper neck. This use of a bite block has several disadvantages, in that tearing of gum tissue and trauma to the interior of the patient's mouth may be caused. The bite block and airway must be inserted over the patient's tongue; however, the face plate restricts the access of a tongue depressor to the corners of the patient's mouth, and hinders this insertion. Also, the position of the strap around the patient's neck is such that it can be dislocated and the tube holder may be dislodged by involuntary motion or spasms of the patient's head.
A similar face-plate device without the bite block and airway is disclosed in U.S. Pat. No. 3,924,636 (Addison). This device and the White device share the disadvantage that access to the patient's mouth is restricted by the face plate. Both devices are unsuitable for medical emergency room applications for this reason. In addition, this device employs a plastery adhesive to fasten the face plate over the patient's mouth, and thus it encounters many of the problems associated with the use of adhesive tape.
U.S. Pat. No. 3,946,742 (Eross) discloses an endotracheal tube holder having a short C-shaped bite member and tube retainer, movably fastened by an arm to an adjustable strap passing around the patient's chin and the back of the upper neck. The tube retainer arm rests against the patient's chin, generally causing discomfort and trauma. Accordingly, the position of the arm must be changed periodically. This device has been found unsatisfactory in many instances because it does not hold the tube firmly in place but allows it to shift position in all directions in the patient's mouth. The commercially available version of this device is provided with an additional stabilizing chin strap (not disclosed in the above patent), but this chin strap is unsuitable for patients with dentures. Further, this device is awkward and difficult to adjust and fasten quickly to an emergency room patient who is moving involuntarily.
Another tube-holding device is disclosed in U.S. Pat. No. 4,114,626 issued to Beran. This patent describes a device for fastening a tube into the nose or mouth of a patient by means of a pressure-sensitive adhesive material. This device suffers from many of the drawbacks associated with the use of adhesive tape or plastery adhesives discussed above. In particular, it lacks the mechanical stability necessary to hold a tube firmly in a fixed position in the patient's mouth. It further results in discomfort to the patient, arising from the use of adhesive patches on the skin.
U.S. Pat. No. 2,831,487 (Tafilaw) discloses a catheter device having a noseplate fitting over the nose of a patient, held in place by an elastic strap around the patient's head. This plate supports and serves as a guide for tubes inserted into the patient's nostrils. These tubes are held in place by channels along the inner surface of the nose plate, and accordingly the tubes must be bent into a hairpin shape at the point directly below the nostrils. Although this device provides an improved method for holding nasal catheters in place, it is unsuitable for endotracheal tubes which are generally larger in diameter, and cannot be subjected to a hairpin bend without collapsing. Accordingly, the concept taught by Tafilaw in unsatisfactory when applied to these endotracheal tubes. In addition, the nose plate in Tafilaw covers the entire nose including the nostrils, and tends to inhibit access to the nostrils which would be desirable during the use of an endotracheal tube.
Yet another tube-holding device is disclosed in U.S. Pat. No. 3,972,321 (Proctor) which teaches a tube-holding fixture fastened by a pair of elastic straps around the back of the patient's head. This device allows the tube to vary in its directional orientation, and does not provide means for holding the tube in a fixed direction into the patient's mouth. Accordingly, it encounters the drawbacks similar to those found in the devices of Eross, Addison, and Beran, described above.